Dasatinib versus imatinib in Japanese patients with newly diagnosed chronic phase chronic myeloid leukemia: a subanalysis of the DASISION 5-year ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-03-24

AUTHORS

Hirohisa Nakamae, Shin Fujisawa, Michinori Ogura, Toshiki Uchida, Yasushi Onishi, Masafumi Taniwaki, Atae Utsunomiya, Kosei Matsue, Yasushi Takamatsu, Kensuke Usuki, Mitsune Tanimoto, Yoji Ishida, Kazuteru Ohashi, Li Li, Masafumi Miyoshi

ABSTRACT

The international phase III DASISION trial demonstrated improved efficacy of dasatinib versus imatinib in treatment-naive patients with chronic myeloid leukemia in the chronic phase (CML-CP). We report efficacy and safety outcomes in a Japanese population from the final, 5-year follow-up of DASISION. At the end of the study, 77% (20/26) of dasatinib-treated and 61% (14/23) of imatinib-treated patients remained on initial therapy. Improved responses were observed in Japanese patients who received dasatinib versus imatinib (complete cytogenetic response: 96 vs 87%; major molecular response: 88 vs 74%; BCR-ABL1 ≤0.0032% International Scale [MR4.5]: 58 vs 52%). In patients who achieved BCR-ABL1 ≤10% at 3 months, 5-year progression-free survival and overall survival rates were high with dasatinib (96 and 96%) and imatinib (88 and 100%). The majority of adverse events were grade 1/2 in Japanese patients. Pleural effusion occurred more frequently in dasatinib-treated Japanese patients versus all patients (42 vs 28%), with no treatment discontinuations. Overall, in Japanese patients, dasatinib maintained its safety profile and had higher or comparable response and survival outcomes compared with imatinib or with all patients in DASISION. These findings demonstrate the long-term efficacy and tolerability of dasatinib and support frontline treatment of Japanese patients with CML-CP with dasatinib. More... »

PAGES

792-804

Journal

TITLE

International Journal of Hematology

ISSUE

6

VOLUME

105

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-017-2208-2

DOI

http://dx.doi.org/10.1007/s12185-017-2208-2

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1084034348

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28341918


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25 schema:description The international phase III DASISION trial demonstrated improved efficacy of dasatinib versus imatinib in treatment-naive patients with chronic myeloid leukemia in the chronic phase (CML-CP). We report efficacy and safety outcomes in a Japanese population from the final, 5-year follow-up of DASISION. At the end of the study, 77% (20/26) of dasatinib-treated and 61% (14/23) of imatinib-treated patients remained on initial therapy. Improved responses were observed in Japanese patients who received dasatinib versus imatinib (complete cytogenetic response: 96 vs 87%; major molecular response: 88 vs 74%; BCR-ABL1 ≤0.0032% International Scale [MR4.5]: 58 vs 52%). In patients who achieved BCR-ABL1 ≤10% at 3 months, 5-year progression-free survival and overall survival rates were high with dasatinib (96 and 96%) and imatinib (88 and 100%). The majority of adverse events were grade 1/2 in Japanese patients. Pleural effusion occurred more frequently in dasatinib-treated Japanese patients versus all patients (42 vs 28%), with no treatment discontinuations. Overall, in Japanese patients, dasatinib maintained its safety profile and had higher or comparable response and survival outcomes compared with imatinib or with all patients in DASISION. These findings demonstrate the long-term efficacy and tolerability of dasatinib and support frontline treatment of Japanese patients with CML-CP with dasatinib.
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35 Japanese patients
36 Japanese population
37 adverse events
38 chronic myeloid leukemia
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40 chronic phase chronic myeloid leukemia
41 comparable responses
42 dasatinib
43 discontinuation
44 efficacy
45 effusion
46 end
47 events
48 final report
49 findings
50 frontline treatment
51 grade 1/2
52 imatinib
53 imatinib-treated patients
54 improved efficacy
55 initial therapy
56 leukemia
57 long-term efficacy
58 majority
59 months
60 myeloid leukemia
61 outcomes
62 overall survival rate
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64 phase
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66 pleural effusion
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